Quality Control/Quality Assurance Specialist

Job Description:

• Quality Management System (QMS) Oversight:
  • Support the implementation, maintenance, and improvement of the company’s QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
  • Maintain document control for quality-related documentation, including specifications, test procedures, and records.
  • Manage company training and qualification records.
• Product and Process Quality Control:
  • Conduct incoming inspections of finished products, materials, components, and supplies to ensure compliance with quality standards and regulatory requirements.
  • Perform testing and inspections of raw materials and components prior to production release.
  • Maintain records of material inspections, testing, and release documentation.
  • Collaborate with production and engineering to address quality issues during manufacturing.
• Cross-Functional Collaboration:
  • Work with engineering, manufacturing, and supply chain teams to resolve quality issues and ensure alignment with quality standards and regulatory requirements.
  • Collaborate with global teams to ensure consistent application of QMS standards.

Requirements:

• Bachelor’s degree in a relevant field (e.g., Engineering, Life Sciences, Quality Assurance).
• Minimum of 3 years of quality control experience in the medical device industry.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Experience with material release processes, inspection techniques, and QMS management.
• Ability to adapt to a fast-paced environment.